{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-23-183869","form_type":"8-K","ticker":"OM","cik":"0001484612","company_name":"Outset Medical, Inc.","filed_at":"2023-07-07T23:59:59+00:00","discovered_at":"2026-05-14T18:03:34.055538+00:00","generated_at":"2026-06-13T11:00:11.245519+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.6,"calibrated_materiality_score":0.6,"confidence":"high","headline":"FDA Warning Letter to Outset Medical over Tablo System promotion and TabloCart clearance","bullets":["FDA Warning Letter dated July 5, 2023 received July 6, 2023, citing two observations: promotional material for CRRT outside Tablo indications, and TabloCart needing 510(k) clearance.","Company believes CRRT issue addressed via labeling/promotional changes; TabloCart launched Q3 2022 with immaterial sales to date.","Warning Letter does not restrict manufacture, shipment, or require withdrawal of Tablo System from U.S. market.","Company to respond within 15 business days; will cooperate with FDA and may submit 510(k) for TabloCart."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-23-183869","json":"https://secwatch.observer/filing/0001193125-23-183869.json","markdown":"https://secwatch.observer/filing/0001193125-23-183869.md","text":"https://secwatch.observer/filing/0001193125-23-183869.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1484612/000119312523183869/0001193125-23-183869-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1484612/000119312523183869/d511727d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-13T11:00:11.245519+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}